Efficacy and safety of sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with hepatitis C virus infection

Abstract

AIMTo assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation (KT) patients with hepatitis C virus (HCV) infection.METHODSThis study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. They were given sofosbuvir combined with daclatasvir, with or without ribavirin. They were monitored regularly during and after the treatment.RESULTSSix patients were recruited in our prospective study cohort. All patients were male and naive to direct-acting antiviral treatment. The treatment duration was 12 wk. Most patients (4/6) were infected with HCV genotype 1b. HCV RNA was undetectable at week 4 after treatment and at the end of treatment in all patients. Sustained virological response rate at 12 wk was 100% (6/6). Two patients had to accept a half dose of sofosbuvir due to serum creatinine elevation during treatment. Kidney function in the remaining patients was stable. No serious adverse events (AEs) were observed. No patient discontinued antiviral therapy due to side effects.CONCLUSIONSofosbuvir and daclatasvir for treatment of KT recipients with HCV infection are highly efficient and safe. Patients tolerated the medications well, and no serious AEs were observed. Larger prospective cohort studies are needed to validate these results.

Cost-effectiveness of using kidneys from hepatitis C nucleic acid test–positive donors for transplantation in hepatitis C–negative recipients

“…Based on the treatment regimens used in prior studies, a 12‐week course of elbasvir/grazoprevir was used as the first course of therapy in the model . It was assumed that up to 4% of patients would require further therapy with an alternate DAA treatment regimen based on published sustained viral response rates . Given that the second DAA treatment regimen may vary depending on viral genotype and prescriber preference, the cost of a second course of therapy was set as equivalent to the cost of the first DAA drug regimen.…”

“…The risk of HCV infection after receiving an organ from an HCV NAT‐positive donor is 100%. The model assumes that the cure of HCV (as defined by achievement of a sustained viral response after 12 weeks of DAA therapy) would be 96% and that 4% of patients would require a second course of treatment . The model assumes that treatment with DAAs would not substantially impact patient quality of life and that after the HCV infection in a recipient was cured, the HCV infection would have no future impact on transplant or patient survival.…”

Hepatitis C virus infection in kidney transplantation‐changing paradigms with novel agents

“…Currently, increasing evidence support the safety and the efficacy of treatment of HCV in Chronic Kidney Disease4‐5 and ESRD patients and particularly in pre and posttransplant patients with minimal side‐effects . Virtually, all patients with HCV can be treated with DAAs.…”

“…29,42 Currently, increasing evidence support the safety and the efficacy of treatment of HCV in Chronic Kidney Dis-ease4-5 and ESRD patients and particularly in pre and posttransplant patients with minimal side-effects. [43][44][45][46][47] Virtually, all patients with HCV can be treated with DAAs. The few patients who fail to achieve SVR after the use of the first generation of agents can be successfully treated with newer, more potent combinations including glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.…”

“…In the studies reviewed above, acute allograft rejection was reported in 7 kidney transplant recipients. [27][28][29][30][31][32][33][34][35][36][37][38]40,[42][43][44][45][46][47][48] Approximately 36% of patients required calcineurin inhibitor dose adjustments during or shortly after DAA therapy; however, whether this is a direct effect of DAA is still unknown. [27][28][29][30][31][32][33][34][35][36][37][38]40,[42][43][44][45][46][47][48] Nevertheless, we recommend close monitoring of calcineurin inhibitor levels during and shortly after DAA therapy until further evidence is available.…”